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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K050541
Device Name OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY
Applicant
Omniguide Communications, Inc.
One Kendall Sq., Bldg. 100
3rd Floor
Cambridge,  MA  02139
Applicant Contact IRINA KULINETS
Correspondent
Omniguide Communications, Inc.
One Kendall Sq., Bldg. 100
3rd Floor
Cambridge,  MA  02139
Correspondent Contact IRINA KULINETS
Regulation Number886.4390
Classification Product Code
HQF  
Date Received03/02/2005
Decision Date 05/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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